A Patient-centered Trial of a Process-of-care Intervention in Hospitalized AKI Patients: the COPE-AKI Trial
Purpose
The COPE-AKI study is a randomized, pragmatic, parallel-arm trial comparing a multimodal intervention to usual care on hospital-free days through 90 days of study follow up. The primary study hypothesis is that patients randomized to the intervention will have increased odds of more hospital-free days through 90 days (primary clinical) compared to those randomized to usual care. Key secondary hypotheses will investigate the impact of the intervention on rates of major adverse kidney events, rates of recurrent AKI, and changes in patient-reported outcomes. Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.
Condition
- Acute Kidney Injury
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Aged ≥ 18 years 2. Kidney Disease Improving Global Outcomes (KDIGO) Stage 2/3 AKI with evidence of persistent AKI (defined as meeting Stage 2+ AKI for 2 consecutive days with serum creatinine concentration measurements >12 hours apart)
Exclusion Criteria
- AKI due to primary glomerulonephritis, renal vasculitis, or thrombotic microangiopathy 2. Diagnosis of end-stage kidney disease (ESKD) at the time of admission, defined as: 1. Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2 2. Previous kidney transplant recipient 3. On chronic dialysis 3. Acute urinary obstruction with rapid kidney function improvement following relief of obstruction 4. Index hospitalization involving nephrectomy 5. Index hospitalization involving solid organ transplant or stem cell/bone marrow transplant 6. Continued dialysis dependence at time of discharge 7. Previous (within 6 months) or new referral to a nephrologist for care specifically for: 1. Previous or new diagnosis of glomerulonephritis 2. Primary electrolyte imbalance disorders unrelated to AKI (e.g., syndrome of inappropriate antidiuretic hormone secretion, Bartter syndrome) 3. Active treatment for acute interstitial nephritis 8. Non-kidney end-organ failure: 1. Class IV congestive heart failure 2. Decompensated cirrhosis with Model For End-Stage Liver Disease (MELD) > 30 or those with a diagnosis of hepatorenal syndrome by the clinical teams 3. End-stage pulmonary disease (advanced stage chronic obstructive pulmonary disease, interstitial lung disease, cystic fibrosis, pulmonary hypertension) 9. Metastatic malignancy or malignancy requiring active treatment (chemotherapy, immunotherapy), such as multiple myeloma 10. Primary goal of care is palliation: life expectancy <6 months 11. Pregnancy 12. Vulnerable populations 1. Persons incarcerated 2. Persons institutionalized 13. Inability to provide informed consent a. Impaired cognition as demonstrated by the Brief Confusion Assessment Method (bCAM) 14. Concurrent enrollment in a separate greater than minimal risk interventional trial 15. Inability to participate in either in-person or remote visits a. Inability to participate as determined by the research team at time of discharge based on disposition (vs uniform decision across site about exclusion based on SNF) 16. Discharge to long-term acute care facility or other hospital-based location
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- This is a randomized, pragmatic, parallel-arm kidney trial conducted to find out if an "enhanced care" team approach can improve a patient's outcomes after hospitalization with acute kidney injury (AKI). Participants (N=2145) will be allocated 1:1 to the intervention or usual care using a web-based system to maintain allocation concealment using stratified randomization with randomly permuted blocks. Randomization will be stratified by clinical site.
- Primary Purpose
- Health Services Research
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Participants and the clinical care teams (nurse navigator, pharmacist, and study physician) will not be masked due to unblinded nature of the intervention. Research coordinators who carry out screening, enrollment, and study visits at baseline, 3, 6 and 12 months will be masked from participant group assignment. Similarly, study visits performed by research coordinator at baseline (enrollment), 3 months and 12 months will be masked. Similarly, assessment of study endpoints will be blinded to group assignment.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Multimodal Process of Care Intervention |
A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. |
|
|
Active Comparator Usual Care |
After receiving the same written information about kidney disease, nephrotoxins to be avoided and importance/need for follow up with a physician as individuals randomized to the multimodal intervention arm, participants randomized to the control arm will receive usual care as specified by their treating providers and will not be followed by nurse navigator, pharmacist, or the study team. The only subsequent study-related activities will be the follow-up study visits for ascertainment of endpoints with the research coordinator. |
|
Recruiting Locations
Nashville, Tennessee 37232
Nashville, Tennessee 37212-2637
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
Detailed Description
The primary study hypotheses for the COPE-AKI study are: compared to usual care, patients randomized to a multimodal intervention will have increased odds of more hospital-free days through 90 days (primary) and lower rates of major adverse kidney events (MAKE) at 180 days, lower rates of recurrent AKI at 180 days, and greater improvements in patient-reported outcomes over 90 days (secondary). The primary outcome is hospital-free days through 90 days of follow up, defined as 90 minus the number of calendar days in the hospital as either an inpatient or on observation status, based on the determination made by the corresponding hospital. Key secondary outcomes include: rates of MAKE (measured at 90, 180, and 365 days), rates of recurrent AKI (90, 180, and 365 days), and 4 patient-report outcomes: global health related quality of life, AKI-specific health related quality of life, provider interactions, and social support (30, 90, 180, 365 days). A multimodal process-of-care intervention that includes 1) study physician oversight and follow up care recommendations at the time of hospital discharge; 2) involvement of a nurse navigator to provide kidney-disease related education, coordinate care, and assess symptoms; and 3) pharmacist-led medication reconciliation and review. Participants in the usual care arm will be provided information about their kidney disease, nephrotoxins to be avoided, and the importance of follow up with a physician will be emphasized.